New CDER No. 2 May Impact FDA's Safety Monitoring Aspirations
Patrizia Cavazzoni, CDER's new deputy director for operations, has safety surveillance background and wants to see FDA continue to grow its capabilities.
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Wall Street Sees Woodcock Commissionership As Positive for Aducanumab, But Eyes Should Be On Cavazzoni
Review extension for Alzheimer’s candidate may be positive for Biogen, but it’s not because Woodcock is acting commissioner. To understand the odds, it may be time to get to better know a new generation of US FDA’s drug review leadership.
CDER Director Woodcock announced that the drug center will soon launch the Drug Risk Management Board, which will coordinate product safety activities among the different offices; Patrizia Cavazzoni, who serves as CDER's deputy director of operations, will chair the board.
Originally used for leadership positions, the alternative pay scale and a revamped hiring pilot are now shortening the time for FDA to onboard even technical staff, but the Office of New Drugs remains 'very understaffed.'